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Compares treatment options for Advanced (Unresectable or Metastatic) Melanoma
Official title Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma
ClinicalTrials.gov ID: NCT07221734
What this study is testing
What is MB11 (Proposed Nivolumab Biosimilar)?
MB11 (Proposed Nivolumab Biosimilar) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced (unresectable or metastatic) melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomised, multicentre, multinational, double-blind, integrated study to sompare the pharmacokinetics, efficacy, safety, and immunogenicity of MB11 versus Opdivo® in subjects with previously untreated advanced (unresectable or Metastatic) Melanoma
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years at the time of signing the informed consent (or adulthood where the legalage of majority in the country is established \>18 years).
- Body weight ≥50 kg at baseline.
- Signed informed consent must be obtained before initiation of any study-specific procedures or treatment.
- ECOG performance status of 0 or 1.
- Life expectancy for at least 3 months.
You likely can't join if
- At least 1 measurable disease lesion by CT or MRI per RECIST v1.1 criteria.
- Tumour tissue from an unresectable or metastatic site of disease, collected within 90 days prior to randomisation, must be available and provided for...
- In the case of prior palliative radiotherapy (on metastatic lesions), this must have been completed at least 2 weeks prior to the study drug...
- Any BRAF mutation status is allowed (BRAF-mutated, BRAF wild-type or non-mutated, or BRAF status unknown).
- Adequate organ function (bone marrow, hepatic, renal, haematologic, endocrine, and coagulation function) should be demonstrated during the screening...
- Haematologic function: absolute neutrophil count ≥1.5 × 109/L, platelets 9≥100 × 10 /L, and haemoglobin ≥9 g/dL. \ \ people should not have received...
See the full eligibility criteria
Who can join
- Age ≥18 years at the time of signing the informed consent (or adulthood where the legalage of majority in the country is established \>18 years).
- Body weight ≥50 kg at baseline.
- Signed informed consent must be obtained before initiation of any study-specific procedures or treatment.
- ECOG performance status of 0 or 1.
- Life expectancy for at least 3 months.
- Untreated, histologically confirmed advanced unresectable Stage III or Stage IV melanoma, as per AJCC 8th Edition staging system. Prior melanoma systemic therapy for earlier stages is allowed for patients who have been...
What rules you out
- At least 1 measurable disease lesion by CT or MRI per RECIST v1.1 criteria.
- Tumour tissue from an unresectable or metastatic site of disease, collected within 90 days prior to randomisation, must be available and provided for PD-L1 testing. All samples must be classified as PD-L1 positive (≥1%...
- In the case of prior palliative radiotherapy (on metastatic lesions), this must have been completed at least 2 weeks prior to the study drug administration. No adjuvant radiation therapies are allowed.
- Any BRAF mutation status is allowed (BRAF-mutated, BRAF wild-type or non-mutated, or BRAF status unknown).
- Adequate organ function (bone marrow, hepatic, renal, haematologic, endocrine, and coagulation function) should be demonstrated during the screening period. This is defined as:
- Haematologic function: absolute neutrophil count ≥1.5 × 109/L, platelets 9≥100 × 10 /L, and haemoglobin ≥9 g/dL. \ \ people should not have received RBC transfusion prior to 14 days beforescreening labs.
- Renal function: serum creatinine level ≤1.5 × ULN or calculated CrCl ≥60 mL/min (using the Cockcroft-Gault formula).
- Liver function: total bilirubin level ≤1.5 × ULN (except people with Gilbert Syndrome, who can have total bilirubin \<3.0 mg/dL), albumin level ≥LLN, AST/ALT ≤2.5 × ULN (≤5 × ULN for people with liver metastases).
- Endocrine function: TSH within normal limits. If TSH is not within normal limits, the subject may still be eligible if T3 and free T4 are within normal limits.
- Coagulation: INR and aPTT ≤1.5 × ULN unless the subject is receiving anticoagulant therapy. people on anticoagulant therapy must be on a stable anticoagulation regimen and have an INR not above the target therapeutic...
- Female people of childbearing potential and their partners, as well as male people with female partners of childbearing potential and their partners, must agree to adhere to the use of a highly effective method of...
- Non-fertile females can be included. Exclusion Criteria:
- people receiving any prior systemic therapy for advanced, unresectable, or metastatic Stage III or Stage IV melanoma (except for palliative radiotherapy, in accordance with Inclusion Criteria #9).
- people receiving any prior immunotherapy (regardless of the melanoma stage), such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-LAG or anti-CTLA-4 therapy (including ipilimumab or any other antibody or drug...
- Participation in another clinical study or treatment with another investigational agent within 4 weeks or 5 elimination half-lives prior to randomisation (whichever is longer)
- Brain metastases or leptomeningeal metastases. A negative brain imaging of less than 90 days prior to screening is required.
- Peritoneal melanomatosis.
- Ocular melanoma, mucosal melanoma and acral lentiginous melanoma.
- History of another malignancy or a concurrent malignancy. Exceptions include people who have been disease-free for 3 years, or people with a history of completely resected non-melanoma skin cancer or successfully...
- Active autoimmune disease that has required systemic treatment in the last 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin or...
- people with hyperthyroidism or hypothyroidism are excluded but those people who are stable on hormone replacement will be allowed.
- Any diagnosis of immunodeficiency, systemic steroid therapy (replacement therapy outlined in Exclusion Criteria #8, inhaled, intranasal, intraocular, or topical steroids are allowed) or any other form of...
- Any major surgery (eg, hip or spine surgery) less than 28 days prior to the first dose of the study drug.
- Having received a solid organ/tissue allogeneic or haematopoietic transplant.
- History and/or current interstitial lung disease or pneumonitis (non-infectious) requiring oral or IV steroids or another immunosuppressive drug.
- Any active or previous infection requiring therapy (oral or systemic) within 30 days prior to the first dose of the study drug.
- Have received or are about to receive a live virus vaccination within 30 days prior to the first dose of the study drug. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
- Known active TB or untreated latent TB.
- Positive serology for human immunodeficiency virus (HIV 1/2), hepatitis B (HBsAg positive and/or HBcAb positive, and HBV DNA positive, refer to Section 8.3.2.1) or hepatitis C (HCVAb positive and HCV RNA positive). In...
- At the time of signing the informed consent, the subject is a regular user (including "recreational use") of any illicit drug or have a recent history (within the past year) of substance abuse (including alcohol).
- Be pregnant or lactating or expecting to conceive during the study or up to 5 months after the last dose of the study drug.
- Immediate family member who is at the research site or sponsoring staff who is directlyninvolved in this study.
- Inability to comply with protocol procedures and/or any other acute or chronic medical condition that may increase the risk for the subject associated with study participation or study drug administration, that may...
The study team makes the final eligibility decision.
Where it's taking place
- Funchal, Portugal
- Chernivtsi, Ukraine
- Ivano-Frankivsk, Ukraine
- Kyiv, Ukraine
- Lutsk, Ukraine
- Ternopil, Ukraine
- Uzhhorod, Ukraine
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Funchal, Portugal; Chernivtsi, Ukraine; Ivano-Frankivsk, Ukraine; Kyiv, Ukraine; Lutsk, Ukraine; Ternopil, Ukraine and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.